Device Recall Vanguard Universal Tibial Resection Block

  • 모델명 / 제조번호(시리얼번호)
    REF. 32-487557/ Lot no 2561334
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • 제품 설명
    Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK || Product Usage: Usage: Used to guide a saw blade in resecting the proximal tibia. Intended to be used with a tibial alignment guide.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA